| Device Type ID | 4439 |
| Device Name | Excimer Laser System |
| Review Panel | Ophthalmic |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Ophthalmic And Ear, Nose And Throat Devices (DOED) Diagnostic And Surgical Devices Branch (DSDB) |
| Submission Type | PMA |
| FDA Device Classification | Class 3 Medical Device |
| Product Code | LZS |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
|
| Device Type ID | 4439 |
| Device | Excimer Laser System |
| Product Code | LZS |
| FDA Device Classification | Class 3 Medical Device |
| Device Problems | |
|---|---|
Adverse Event Without Identified Device Or Use Problem | 2026 |
Laser | 233 |
System | 229 |
Insufficient Information | 109 |
Device Operates Differently Than Expected | 94 |
Device Displays Incorrect Message | 74 |
Improper Or Incorrect Procedure Or Method | 39 |
Unintended Movement | 22 |
Overcorrection | 21 |
Failure To Align | 20 |
Use Of Device Problem | 19 |
Use Of Incorrect Control Settings | 18 |
Appropriate Term/Code Not Available | 16 |
Unexpected Therapeutic Results | 16 |
Failure To Cut | 13 |
Energy Output Problem | 10 |
Device Operational Issue | 9 |
Gas Leak | 9 |
Suction Problem | 8 |
Energy Output To Patient Tissue Incorrect | 7 |
Patient-Device Incompatibility | 7 |
Device Inoperable | 7 |
Mechanical Problem | 6 |
Computer Software Problem | 6 |
Loss Of Power | 5 |
Therapeutic Or Diagnostic Output Failure | 5 |
Smoking | 4 |
Failure To Capture | 4 |
Decrease In Suction | 4 |
Calibration Problem | 3 |
Gas Delivery System | 3 |
Device Issue | 3 |
Fumes Or Vapors | 3 |
Leak / Splash | 3 |
Improper Device Output | 3 |
Shutter | 3 |
Energy Spectrum Incorrect | 3 |
Incorrect Measurement | 3 |
IOL (Intraocular Lens) Implant | 2 |
Electrical /Electronic Property Problem | 2 |
Unintended System Motion | 2 |
Failure To Sense | 2 |
Microscope | 2 |
Device Sensing Problem | 2 |
Failure To Fire | 2 |
Optical Problem | 2 |
Failure To Deliver Energy | 2 |
Device Emits Odor | 2 |
Cylinder | 2 |
Failure To Power Up | 2 |
Inadequate Or Insufficient Training | 2 |
Display Or Visual Feedback Problem | 2 |
Scanner | 2 |
Malposition Of Device | 2 |
Material Distortion | 1 |
Moisture Or Humidity Problem | 1 |
Positioning Problem | 1 |
Image Orientation Incorrect | 1 |
Loose Or Intermittent Connection | 1 |
Break | 1 |
Charred | 1 |
Misfocusing | 1 |
No Device Output | 1 |
Inaccurate Delivery | 1 |
Gel Leak | 1 |
Defective Device | 1 |
Inadequate User Interface | 1 |
Output Problem | 1 |
Torn Material | 1 |
Noise, Audible | 1 |
Device Handling Problem | 1 |
Air Leak | 1 |
Computer Operating System Problem | 1 |
Expulsion | 1 |
Reset Problem | 1 |
Therapy Delivered To Incorrect Body Area | 1 |
Temperature Probe | 1 |
Detachment Of Device Component | 1 |
Ambient Temperature Problem | 1 |
Increased Sensitivity | 1 |
Application Interface Becomes Non-Functional Or Program Exits Abnormally | 1 |
Power Conditioning Problem | 1 |
Inappropriate Shock | 1 |
Device Stops Intermittently | 1 |
Sparking | 1 |
Fire | 1 |
Programming Issue | 1 |
Communication Or Transmission Problem | 1 |
Output Above Specifications | 1 |
Device Difficult To Program Or Calibrate | 1 |
Self-Activation Or Keying | 1 |
Intermittent Continuity | 1 |
Optical Distortion | 1 |
Failure To Calibrate | 1 |
| Total Device Problems | 3139 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Nidek Inc | II | Mar-20-2017 |
| 2 | Nidek Inc | II | Jun-04-2015 |
| 3 | Nidek Inc | II | Nov-17-2014 |